Registration Dossier

Administrative data

Description of key information

Concentrations higher than 10% induced weak to strong concentration dependant skin irritation. Therefore the maximum concentration considered for skin irritation unaffected by skin irritation was 10%.

At 10% of Lime Oxide in ethanol, no allergic potential was observed under the test conditions and Lime Oxide was well tolerated on the skin of guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
open epicutaneous test
Justification for non-LLNA method:
A valid in vivo test is available which follows accepted guidance for skin sensitisation.
In addition, this means no further unnecessary animal work is required.
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
One to six experimental groups and one control group of six to eight animals.
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
3, 10, 30 and 100 %
Day(s)/duration:
21 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
30%
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
6-8
Details on study design:
On day "0" application of 0.1 mL of the test material on the flank skin of 6 to 8 guinea pigs.
Applied repeatedly for 3 weeks or 5 times weekly during 4 weeks.
The application site was left uncovered.
Challenge controls:
The minimumirritating concentration was used in order to confirm biological activity determined before starting the induction (day -1).
0.025 mL of each concentration was applied to the skin.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Concentrations higher than 10% induced weak to strong concentration dependant skin irritation. Therefore the maximum concentration considered for skin irritation unaffected by skin irritation was 10%.
At 10% of Lime Oxide in ethanol, no allergic potential was observed under the test conditions and Lime Oxide was well tolerated on the skin of guinea pigs
Executive summary:

No allergic reactions were observed. Therefore no classification is required.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification